Back to resultsTBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Primary Purpose
Vaccine Responsiveness in Allergy, Vaccine Responsiveness During Allergy De-sensitization Treatment
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
TBE booster vaccination
Sponsored by
About this trial
This is an interventional prevention trial for Vaccine Responsiveness in Allergy
Eligibility Criteria
Inclusion Criteria:
- completed primary TBE immunization + at least one booster immunization
- adults of both sexes between 18 and 60 years of age
- willingness to sign written informed consent form
Exclusion Criteria:
- age < 18 and > 60 years
- prior TBE infection
- Hepatitis A vaccination
- pregnancy and breast feeding
- acute infection on day of inclusion (day 0), body temperature >37,9°C
- concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
- administration of other vaccines 4 weeks before/after TBE vaccination
- planned surgery within 2 weeks before/after TBE vaccination
- Start of de-sensitization and the first 4 weeks of allergen dose escalation
- any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
- history of malignant disease within the last 5 years
- autoimmune diseases
- drug addictions
- plasma donors
- receipt of blood transfusions or immuno globulins within 3 month before study entry
Sites / Locations
- Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Allergic patients
Allergic patients with de-sensitization treatment
Healthy controls
Arm Description
Allergic patients receive TBE booster vaccination
Allergic patients with de-sensitization treatment receive TBE booster vaccination
Healthy controls receive TBE booster vaccination
Outcomes
Primary Outcome Measures
Humoral TBE Immunity
Geometric mean titers of TBE specific neutralizing Abs
Secondary Outcome Measures
Cellular Immune Response - Cytokine Production
cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)
Cellular Immune Response - Lymphocyte Subpopulations
analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes
TBE Titer Course
Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination
Full Information
NCT ID
NCT02511535
First Posted
July 23, 2015
Last Updated
October 3, 2019
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02511535
Brief Title
TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Official Title
TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. The investigators aim to find out whether this influences immune responses to primary and booster vaccinations.
Detailed Description
Allergic patients generally have an altered immunologic profile (Th2 bias), and allergic individuals undergoing de-sensitization treatment display an increased production of immune suppressive cytokines. The investigators measure humoral and cellular immune responses to routine vaccination (Tick-borne Encephalitis [TBE] booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Responsiveness in Allergy, Vaccine Responsiveness During Allergy De-sensitization Treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allergic patients
Arm Type
Experimental
Arm Description
Allergic patients receive TBE booster vaccination
Arm Title
Allergic patients with de-sensitization treatment
Arm Type
Experimental
Arm Description
Allergic patients with de-sensitization treatment receive TBE booster vaccination
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
Healthy controls receive TBE booster vaccination
Intervention Type
Biological
Intervention Name(s)
TBE booster vaccination
Other Intervention Name(s)
Vaccine: FSME-Immun® (Fruehsommer-Meningoencephalitis), One dose (0.5 ml) contains:, 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudoerfl),, adsorbed on aluminium oxide, hydrated (0.35 milligrams Al3+), Manufacturer: Baxter Innovations GmbH
Primary Outcome Measure Information:
Title
Humoral TBE Immunity
Description
Geometric mean titers of TBE specific neutralizing Abs
Time Frame
one month after booster vaccination
Secondary Outcome Measure Information:
Title
Cellular Immune Response - Cytokine Production
Description
cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)
Time Frame
before (day 0) and 1week after booster vaccination
Title
Cellular Immune Response - Lymphocyte Subpopulations
Description
analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes
Time Frame
before (day 0) and 1week after booster vaccination
Title
TBE Titer Course
Description
Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination
Time Frame
before (day 0) until 6 months after booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
completed primary TBE immunization + at least one booster immunization
adults of both sexes between 18 and 60 years of age
willingness to sign written informed consent form
Exclusion Criteria:
age < 18 and > 60 years
prior TBE infection
Hepatitis A vaccination
pregnancy and breast feeding
acute infection on day of inclusion (day 0), body temperature >37,9°C
concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
administration of other vaccines 4 weeks before/after TBE vaccination
planned surgery within 2 weeks before/after TBE vaccination
Start of de-sensitization and the first 4 weeks of allergen dose escalation
any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
history of malignant disease within the last 5 years
autoimmune diseases
drug addictions
plasma donors
receipt of blood transfusions or immuno globulins within 3 month before study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Wiedermann, MD, PhD
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
29673942
Citation
Garner-Spitzer E, Seidl-Friedrich C, Zwazl I, Hofer M, Kinaciyan T, Jarisch R, Stiasny K, Zlabinger GJ, Kundi M, Wiedermann U. Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias. Vaccine. 2018 May 11;36(20):2816-2824. doi: 10.1016/j.vaccine.2018.03.076. Epub 2018 Apr 16.
Results Reference
derived
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TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
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